The tragedy of thalidomide

Big Pharma’s deceptive tactics continue today

by Janet Currie

Recently, I came across an article in the Sunday Times about how Germany has reneged on a decades-old agreement to pay for the health needs of 465 surviving British victims of the drug thalidomide. These adults, now between 55-65, were born with severe birth defects after their mothers used the drug for morning sickness during the first three months of their pregnancies.

As thalidomide victims age, their health needs become more serious, complex and costly. Their parents, if still alive, are elderly. In many cases, these parents have borne the brunt of their children’s care and are no longer able to do so.

In 1956, thalidomide was synthesized, marketed and sold by Chemie Grunenthal, a West German drug company that had an unsavoury past. Two of its founders had been prominent Nazis and a number of its scientists had carried out drug experimentation in German labor camps.

In the 1950s and 1960s, thalidomide was sold in 46 different countries, including Canada, under a wide variety of trade names including Contergan, Kavadon, Distaval and Talimol (in Canada). Thalidomide was described as a “wonder drug” and was said to cure insomnia, eliminate pain and headaches and reduce nausea in early pregnancy (an unapproved or “off-label” use).

In Germany, it became the second best-selling drug after aspirin, partly because it was cheap and available without a prescription. Over 700,000 people were using it on a regular basis. Parents gave it to their children to sedate them and it earned the name of “West Germany’s babysitter.” Grunenthal marketed thalidomide by showing peaceful nature scenes and suggesting the drug could combat work stress.

Over 24,000 babies born to mothers worldwide who were prescribed thalidomide during the first three months of pregnancy were victims of a variety of serious deformities, including misshapen, rudimentary or deformed limbs and hands and feet, deafness, sight problems, (including blindness) and defects of the heart, kidneys, reproductive and digestive systems.

At least 123,000 other babies affected by thalidomide were stillborn or the women miscarried. The greatest number of victims were from Germany (6,000). There were about 200 victims in Canada, but the actual number is unknown because record-keeping at the time was poor. In Canada, legal battles over victim identification and compensation exist to this day.

Thalidomide has the dubious title of being the largest global man-made drug disaster. Sales of the drug did not begin in Canada until the drug was approved in April 1961. However, in 1959, the company was already providing free samples of thalidomide to Canadian doctors to give to their patients. At the time, there were no Canadian laws that regulated the distribution of free samples by doctors. Doctors who agreed to distribute the drug were called “clinical investigators” and the company used these relationships to build brand loyalty. Similar methods to build brand loyalty to specific drugs among physicians exist to this day. Canadian mothers who received thalidomide through free samples were never given prescription records and, because of this, victims were often ineligible for compensation.

Thalidomide was never approved in the US due to the efforts of Canadian-born pharmacologist Dr. Frances Oldham Kelsey. She had just been appointed as a medical reviewer by the US Food and Drug Administration and one of the first drugs she was given to approve was thalidomide because it was considered to be “an easy file.” The US company licensed to sell the drug was so confident the drug would be approved that it had already started a huge promotional campaign.

But Kelsey refused to approve the drug because the company did not provide satisfactory clinical evidence on its toxicity. When the company learned it had to resubmit its application, there was enormous pressure exerted on the FDA and on Kelsey. The young scientist was called “nitpicking, stubborn, unreasonable and obstructionist.” And many of the attacks were gender-related. By the time the company’s re-application was reviewed, reports were already appearing in the British Medical Journal about the drug causing nerve damage in adults. It was never approved.

Kelsey saved thousands of babies from the effects of thalidomide and became a national hero. But even though thalidomide was never approved in the US, the company gave 20,000 free samples to doctors to give to patients. Fortunately, only a few of these patients were pregnant and there were only about 17 victims.

Chemie Grunenthal told the public and patients that thalidomide was completely safe and non-toxic to fetuses. However, in a subsequent seven-year trial in Germany, the company said it never tested the effects of the drug on fetuses because that wasn’t common practice at the time. This was later shown to be untrue; the effects of prescribing drugs to pregnant women had been researched since the 1940s.

Results from this trial also found evidence that when the links between thalidomide and nerve damage were discovered by the Grunenthal, it gave out false information and hushed up any internal knowledge it had about the drug’s risks. It also came to light that, by the time the BMJ published information about the drug’s toxicity, Grunenthal had already received hundreds of reports of serious side effects. This report concluded that, since the drug was so profitable, the company wanted to keep it on the market for as long as possible.

The first documented thalidomide victim was identified in 1956. Ironically, it was an employee of Grunenthal, who received it before the drug was publicly sold. After increasing evidence that the drug was causing deaths and serious malformations in babies, the company withdrew it from the West German market on November 27, 1961. UK and Australia withdrew it a short time later. Canada, however, did not withdraw the drug until March 1962, a full three months after the manufacturer had withdrawn it in Germany and well after its adverse effects were known.

With only a few exceptions, the rights and needs of thalidomide victims and their families in most countries, including Canada, were ignored or delayed. The first compensation package for victims by the Canadian government was in the 1990s when the government distributed lump sum payments of $52,000-82,000 to 109 victims.

In 2015, after pressure from the Thalidomide Victims Association, the Conservative government added a one-time $125,000 lump sum payment with a yearly pension depending on the level of disability. However, the requirements to claim this support were so onerous that many thalidomide victims were ineligible. Parents (now elderly) were required to produce doctors’ records from the 1950s or have a sworn affidavit from a doctor practising at that time!

In the 2018 budget, the current Liberal government agreed to expand the eligibility for thalidomide assistance. However, the attitude of many countries and health regulators seemed to be to wait it out until the majority of victims and their caregivers had died. Perhaps this also explains why it took 50 years (until 2012) for Grunenthal to issue an official apology about the harms thalidomide had caused.

Although it occurred almost 60 years ago, the thalidomide tragedy reflects many aspects of our troublesome relationship with pharmaceutical companies and health regulators that remain relevant to this day, including how drug companies sometimes hide, ignore or minimize serious adverse drug reactions, how the promotion of drugs to doctors and the public sometimes exaggerates benefits and downplays risks, the problems of using drugs for unapproved uses, how the withdrawal of unsafe drugs is delayed to maximize profit and how efforts to hold drug companies accountable for the damage they do are frequently inadequate and unjust.

The stories of drugs like Vioxx, an arthritis pain medication withdrawn from the market after it caused heart attacks and strokes, or Prepulsid, a drug used off-label that caused deaths due to heart arrhythmias and was kept on the Canadian market after its risks were known, are two recent examples of some of these problems.

Thalidomide reminds us that, even though drugs are often helpful and can be life-saving, pharmaceutical companies are private corporations that want to get through the drug approval process as quickly as possible so they can market and sell their products to the widest audience possible for as long as they can.

We need to rely on our own healthy skepticism rather than relying on Health Canada to ensure the drugs we use are necessary, effective and safe. In terms of Health Canada, this means better and more transparent ways of monitoring drug safety and taking unsafe drugs off the market in a timely way.

Resources

Documentaries and web-based information on thalidomide:

• Thalidomide: how men who blighted lives of thousands evaded justice.
• Canadian documentary on the forgotten thalidomide children
• The story of Vanessa Young

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Janet Currie is a writer, policy analyst and researcher. She works in the fields of justice and health and has a specific interest in medication (its use, safety and effectiveness). She is completing a PhD on off-label prescribing at UBC. While she cannot answer specific health concerns, if you have comments about the article, please contact her at note123@shaw.ca

source photo © Zatletic / montage by Tom Voydh